Background

Medlab’s historical work saw the introduction of ARTG (Australian Register of Therapeutic Goods, controlled by the Australian Regulatory, the Therapeutics Good Administration (TGA)). These products were “listed” medicines in accordance with the Australian TGA guidelines.

These products included general probiotics as well as specific formulations for infants, people with Irritable Bowel Syndrome (IBS), and depression.

To support both products and add to the evolving knowledge regarding the human microbiome, Medlab patented and published extensively in this area.

At the time Medlab’s focus was on ingesting probiotics to support the gastrointestinal microbiome - the work generated in this area gave rise to the NanoCelle® delivery platform to provide a means of by-passing first-pass metabolism.

Examples of the ARTG listing Medlab Clinical Limited:

• MultiBiotic™ - a general multi strain probiotic for gastrointestinal health

• EnBiotic™ - a specific probiotic for irritable bowel syndrome

• NRGBiotic™ - a patented, 1st in class, clinically trialled probiotic for major depressive disorders

Other examples included a combined rehydration and probiotic formulation called ORSBiotic™ designed to replace fluids lost due to vomiting, diarrhoea and strenuous physical activity, providing essential electrolytes together with selected probiotic species to provide therapeutic support for various triggers of diarrhoea and associated symptoms. A historical patient CMI is available here.